Covaxin facing shortage of volunteers for phase 3 trials, says AIIMS

The Phase III clinical trial for Bharat Biotech's vaccine candidate Covaxin is witnessing a shortage of volunteer participation, with a high refusal rate of 70% to 80%, a senior AIIMS doctor said

With the start of Covid vaccination an immediate future in India, the phase III clinical trial for indigenously-developed Bharat Biotech's vaccine candidate Covaxin is witnessing a shortage of volunteer participation, with a high refusal rate 70 per cent to 80 per cent, a senior AIIMS doctor said on Wednesday.

"When the clinical trial began, we wanted 100 volunteers and received over 4,500 applications. In phase II, we wanted 50 and received 4000 applications. In phase III, now when wanted 1,500-2,000 participants, we could only recruit about 200 participants as of now. It is happening because people are thinking why to volunteer when a vaccine is coming for everyone soon," Dr Sanjay Rai, Professor of Community Medicine at AIIMS told ANI.

 

Dr Rai said there is not much excitement for clinical trial as people are over-excited about the vaccine, and added that as per the guidelines of the Central government, in the first phase, vaccines will only be administered to priority groups.

"Fact is that, even if a vaccine comes, it'll be given to healthcare providers, frontline workers, elderly with co-morbidities first. But people think they will get vaccine soon," he added.

The government's National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) recommended that prioritised population groups will specifically be vaccinated.

The group include--approximately one crore, healthcare workers (HCWs) healthcare providers and workers in the healthcare setting; about two crore frontline Workers (FLWs)which includes personnel from state and central police, armed forces, home guards, civil defence and disaster management volunteers, municipal workers; approximately 27 crores prioritized age group population above 50 years and persons below 50 years with associated co-morbidities.

"This scenario was not seen in the phase I and phase II clinical trial...There was no refusal rate at all," Dr Rai who is a principal investigator for COVAXIN clinical trial said.

Dr Rai opined that because phase III is a double-blind clinical trial, the authorities have to inform the participants that 50 per cent would receive the vaccine and other 50 per cent would receive the placebo.

"After listening to this most of the participants refuse to participate in the clinical trial saying that vaccine is coming soon. Now we are planning to create awareness among people through advertisements, email and telephone. It is important for people to participate in the clinical trial to get a safe and efficient vaccine," he stated.

The doctor added that authorities are hoping to finish the phase III clinical trial by the end of this month (December).

Meanwhile, the Centre has prepared a detailed guideline for mass Covid vaccination. The Union Health Ministry has also directed the states to prepare for adverse events post Covid-19 vaccination as can't be ruled out.

Till the time there is no vaccine, people have to strictly follow Covid-19 appropriate behaviour by wearing a face mask, washing or sanitising hands and maintaining social distancing.